Software Validation Engineer

Merck KGaA-posted about 1 month ago
Full-time • Mid Level
Hybrid • Saint Louis, MO
5,001-10,000 employees
Chemical Manufacturing
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Ready to explore, break barriers, and discover more? We know you've got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us. As a Software Validation Engineer at MilliporeSigma, you will guide and direct validation projects for all Life Science digital products, applications, and computerized systems. You will serve as a subject matter expert, providing leadership on computerized systems validation, quality governance, and regulatory compliance, including travel for critical site support during inspections or major projects. Responsibilities include the following:

  • Lead the qualification and validation of diverse digital products, computerized systems, and software solutions, including Control Systems, Cloud-based solutions, and Operational Technology (OT)
  • Execute the full validation lifecycle (IQ, OQ, PQ, protocols, test scripts, infrastructure qualification, backup/restoration, and audit trail testing) in both GMP and Non-GMP environments
  • Ensure compliance with global regulatory guidelines including GAMP, QMS, 21 CFR Part 11, and Annex 11
  • Perform critical assessments (Risk, Functional Risk, Data Integrity, FMEA) to define requirements and controls prior to development and verify tested systems meet those standards
  • Review and approve validation documentation, including URS, Functional/Design Specifications, and Test Scripts for COTS and new products
  • Develop and manage core validation documents, such as Test Scripts/Protocols, Test Summary Reports, Traceability Matrices, and Validation Summary Reports
  • Manage quality system activities, including Operational Change Control, Deviation/CAPA management, customer complaint handling, and periodic review/re-validation
  • Act as the validation expert during audits, effectively presenting and explaining qualification documents and reports to regulatory agencies, internal/external auditors, and customers
  • Bachelor's degree in Chemistry, Chemical Engineering, Computer Science, Biomedical engineering or other Life Science discipline
  • 5+ years of experience in software and/or computerized validation
  • Excellent written and verbal skills
  • Excellent computer skills and experience in Project Planning, Word, Excel, PowerPoint, SharePoint
  • Prior automation testing experience
  • Qualified systems and supported process validation, ensuring compliance with GMP, GCP, GLP, GAMP, and Part 11 regulations
  • Global travel based on the need of project and business
  • health insurance
  • paid time off (PTO)
  • retirement contributions
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